Hemafluor Reagent Kit
FDA 510(k) K860309 · Helena Laboratories
510(k) numberK860309
Submission
- Device name
- Hemafluor Reagent Kit
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- January 28, 1986
- Decision date
- July 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
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Questions and answers
When was Hemafluor Reagent Kit cleared by the FDA?
Hemafluor Reagent Kit (K860309) received a 510(k) decision of Substantially Equivalent on July 14, 1986, 167 days after the submission was received.
What is the product code of K860309?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.